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In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.
In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.
The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline irrigation | Experimental | CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones. |
|
| None saline irrigation | No Intervention | CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline irrigation | Procedure | 100ml saline irrigation after CBD stone removal with routine ERCP procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Recurrence of CBD Stones | Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Cholangitis | Temperature should be more than 38 ℃, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal | 3 years |
| Number of Participants with Pancreatitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenbo Meng, MD,PhD | Hepatopancreatobiliary Surgery Institute of Gansu Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatopancreatobiliary Surgery Institute of Gansu Province | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29610513 | Background | Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27. | |
| 19249039 |
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| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| D042882 | Gallstones |
| D002761 | Cholangitis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after surgery, and there are also radiographic evidence suggesting the shape of pancreas has changed |
| 3 years |
| Number of Participants with Bleeding | Was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl | 1 month |
| Number of Participants with Perforation | Was defined as the presence of air or contrast in the retroperitoneal space | 1 month |
| Procedure time of each case | From the moment the endoscope entered, to the moment withdraw the scope | 7 days |
| Ang TL, Teo EK, Fock KM, Lyn Tan JY. Are there roles for intraductal US and saline solution irrigation in ensuring complete clearance of common bile duct stones? Gastrointest Endosc. 2009 Jun;69(7):1276-81. doi: 10.1016/j.gie.2008.10.018. Epub 2009 Feb 26. |
| 37152367 | Derived | Lin Y, Yang M, Cao J, Zhang X, Mi N, Yang X, Wang H, Gao L, Bai M, Fu W, Li X, Yue P, Yuan J, Meng W, Leung JW. Saline irrigation for reducing the recurrence of common bile duct stones after lithotripsy: a randomized controlled trial. EClinicalMedicine. 2023 Apr 27;59:101978. doi: 10.1016/j.eclinm.2023.101978. eCollection 2023 May. |
| D002137 |
| Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001649 | Bile Duct Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |